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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter FPart 600 → Subpart C


Title 21: Food and Drugs
PART 600—BIOLOGICAL PRODUCTS: GENERAL


Subpart C—Establishment Inspection


Contents
§600.20   Inspectors.
§600.21   Time of inspection.
§600.22   [Reserved]

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§600.20   Inspectors.

Inspections shall be made by an officer of the Food and Drug Administration having special knowledge of the methods used in the manufacture and control of products and designated for such purposes by the Commissioner of Food and Drugs, or by any officer, agent, or employee of the Department of Health and Human Services specifically designated for such purpose by the Secretary.

[38 FR 32048, Nov. 20, 1973]

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§600.21   Time of inspection.

The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.

[38 FR 32048, Nov. 20, 1973, as amended at 48 FR 26314, June 7, 1983; 64 FR 56449, Oct. 20, 1999; 84 FR 12508, Apr. 2, 2019]

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§600.22   [Reserved]

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